# K031676: Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 20, 2003 after 174 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895631 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923065: Baxter Personal Cycler Autommated Peritoneal Dial, Baxter Healthcare Corp (1994) Summary page 1.
- K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469, Baxter Healthcare Corp (2001) Summary page 1.
- K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine, Baxter Healthcare Corp (1997) Summary page 1.
- K895631: Disconnect Caps Product Codes 5C4212 and 5C4466, Baxter Healthcare Corp (1990) Summary page 1.

## Recalls of this device
- Dec 5, 2003 · Not classified · Z-0340-04: Reports of loosening of the connections and disconnection of the device.
- Dec 5, 2003 · Not classified · Z-0341-04: Reports of loosening of the connections and disconnection of the device.

## Indications for use
The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set. The Homechoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the Homechoice Automated Personal Cycler with Low Fill Mode Drain Logic. The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy. The Homechoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the Homechoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

Source page: https://510kreport.com/device/K031676
Methodology: https://510kreport.com/methodology